MAUDE Adverse Event Report: AV-TEMECULA-CT PROSTAR XL SUTURE-MEDIATED CLOSURE; SUTURE MEDIATED CLOSURE

Catalog Number 12322-02

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

It was reported that during unpacking of the device, the packaging was found opened.The pouch seal was open in the box.The prostar xl device was not sterile.The device was not used.There was no patient involvement.Another prostar xl device was used with no issue.No additional information was provided.

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation.The reported unsealed device packaging could not be confirmed.The vendor seals of the pouch were returned unsealed with a white, cloudy appearance at the unsealed portions, suggesting the seal was originally sealed.Based on visual analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no associated non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database indicated there had been no similar incidents of unsealed device package reported for this lot.Based on the information reviewed, there is no indication of a product deficiency.

• Brand Name: PROSTAR XL SUTURE-MEDIATED CLOSURE
• Type of Device: SUTURE MEDIATED CLOSURE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): REDWOOD CITY, CA USA REG# 2953144; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4282274
• MDR Text Key: 5229164
• Report Number: 2024168-2014-07799
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P960043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 12322-02
• Device Lot Number: 40708K1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2015
• Initial Date FDA Received: 11/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1